BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 13061053 · Received December 22, 2021

    Report

    Report Number
    2939274-2021-07193
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER IS A SYNTHES EMPLOYEE. PRODUCT CODE #: 314.03, SYNTHES LOT #: 4032451, SUPPLIER LOT #: 4032451, RELEASED TO WAREHOUSE: DECEMBER 10, 1999, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE COMPLAINT DEVICE SMALL HEXAGONAL SCREWDRIVER SHAFT (PRODUCT CODE: 314.03, LOT NUMBER: 4032451) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. THE DRIVING TIP OF THE SCREWDRIVER SHAFT WAS STRIPPED, AND THE ITEM SHOWED SIGNS OF CORROSION. DEVICE/DEFECT IDENTIFIED: YES. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF THE DRAWINGS WERE REVIEWED. SMALL HEX SCREWDRIVER SHAFT 100MM. DIMENSIONAL INSPECTION: DIAMETER: MEASURED DIMENSION, CONFORMING. MEASURING DEVICE USED: CALIPER. COMPLAINT CONFIRMED: COMPLAINT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. CONCLUSION: THE DRIVING TIP OF THE DRIVER SHAFT WAS STRIPPED AND PRESENTED SIGNS OF CORROSION, HENCE THE COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED DURING INVESTIGATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER INSPECTION OF THE BACK UP INSTRUMENTS, THESE WERE SET ASIDE FOR COMPLAINTS. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963725 SMALL HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.03 4032451 10886982188380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 3.5 VA LCKNG SCR SLF-TPNG/SD/85| BENDING IRON FOR 2.7MM & 3.5MM PLATES| CANN CONNECTING SCREW FOR STD INSRT H&LE| CANNULATED 2.5MM HEXAGONAL SCREWDRIVER| DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS| DEPTH GAUGE FOR LCKNG SCRS TO 100| DEPTH GAUGE FOR LCKNG SCRS TO 100| EXTRACTION SCR FOR TI FEM & TIB NAIL| GD BLK 2.7/3.5 VA ANTLAT DSTL TIB PL/RT| SCRDRIVERSHAFT-HEX-LRG Ø3.5 L165 F/QC| SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE| SDDRIVE SCREWDRIVER SHAFT T8 105MM| SHARP HOOK| UNK - SCREWDRIVERS